EUCAN Regulatory Therapeutic Area Team Lead – Oncology Specialist

Vor 4 Tagen


Zürich, Zürich, Schweiz Takeda Vollzeit

Leadership Role

As part of the Takeda team, we are seeking an experienced EUCAN Regulatory Therapeutic Area Team Lead to oversee and direct all regulatory activities related to oncology products. This leadership role requires strategic leadership and oversight to ensure the successful development and lifecycle management of oncology products in the EUCAN region.

Key Responsibilities

  • Provides strategic leadership and oversight to a team of regulatory strategists who define, develop, and lead Europe & Canada (EUCAN) regulatory strategies to maximize regulatory success.
  • Ensures recruitment, line management, and development of direct reports.
  • Provides strategic and tactical advice and guidance on regional regulatory expertise to regional and global leadership teams.
  • Ensures team resourcing and appointment of appropriately skilled EUCAN Regulatory Leads to Global Regulatory Teams and Submission Working Groups.
  • Manages or supports and oversees health authorities interactions in the region and key external stakeholder management.
  • Develops capabilities of staff members and ensures the planning and management of all regulatory activities throughout the product life cycle.
  • Presents regional regulatory strategies to leadership/senior management and ensures that staff members stay current with regulations/guidance in the region.
  • Provides regulatory expertise to senior management on drug development, registration, and/or post-marketing compliance and life-cycle management.

Requirements

  • A minimum of 15 years of regulatory affairs experience in the pharmaceutical/biotechnology industry within the EU region.
  • Comprehensive knowledge of regional regulatory requirements and guidelines for oncology products.
  • Proven track record of successful regulatory submissions and approvals for oncology products.
  • Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively.
  • Strategic thinker with exceptional problem-solving and decision-making capabilities.

About Takeda

Takeda is committed to fostering diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.



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